16-week efficacy and 3-year safety, tolerability and efficacy of secukinumab in active ankylosing spondylitis patients

A randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001090-24-DE

Enrollment

222

Registered

2013-10-24

Start date

2014-01-08

Completion date

Unknown

Last updated

2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing spondylitis MedDRA version: 18.1 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Secukinumab CAS Number: 1229022-83-6 Current Sponsor code: AIN457

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Moderate to severe AS - Prior radiographic evidence according to the Modified NY Criteria (1984) - Inadequate response to NSDAIDs Other protocol-defined inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 220 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: - Pregnancy or lactation - Ongoing infectious or malignant process on a chest X-ray or MRI - Previous exposure to IL-17 or IL-17R targeting therapies - Previous exposure to any biological immunomodulating agent excluding TNF antagonists - Previous cell depleting therapy Other protocol-defined exclusion critera may apply

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate that the efficacy of at least one dose of secukinumab at Week 16 is superior to placebo based on the proportion of subjects achieving an ASAS 20 (Assessment of SpondyloArthritis International Society criteria) response in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF alpha therapy.;Secondary Objective: -To demonstrate that the efficacy of at least one dose of secukinumab at Week 16 is superior to placebo based on: 1- the proportion of subjects achieving an ASAS 40 response 2- the change from baseline of hsCRP 3- the proportion of patients meeting the ASAS 5/6 response criteria 4- the change from baseline in total BASDAI 5- the change from baseline in the proportion of patients achieving ASAS partial remission -To assess PFS usability utilizing the Self-Injection assessment checklist and Possible Hazard assessment checklist and to assess subject satisfaction with PFS utilizing the SIAQ -Overall safety and tolerability of secukinumab LiV and PFS formulations compared to placebo as assessed by vital signs, clinical laboratory values and adverse events monitoring;Primary end point(s): Assessment of Spondyloarthritis International Society criteria / ASAS 20 response;Timepoint(s) of evaluation of this end point: 16 weeks	—

Measure

Time frame

Main Objective: To demonstrate that the efficacy of at least one dose of secukinumab at Week 16 is superior to placebo based on the proportion of subjects achieving an ASAS 20 (Assessment of SpondyloArthritis International Society criteria) response in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF alpha therapy.;Secondary Objective: -To demonstrate that the efficacy of at least one dose of secukinumab at Week 16 is superior to placebo based on: 1- the proportion of subjects achieving an ASAS 40 response 2- the change from baseline of hsCRP 3- the proportion of patients meeting the ASAS 5/6 response criteria 4- the change from baseline in total BASDAI 5- the change from baseline in the proportion of patients achieving ASAS partial remission -To assess PFS usability utilizing the Self-Injection assessment checklist and Possible Hazard assessment checklist and to assess subject satisfaction with PFS utilizing the SIAQ -Overall safety and tolerability of secukinumab LiV and PFS formulations compared to placebo as assessed by vital signs, clinical laboratory values and adverse events monitoring;Primary end point(s): Assessment of Spondyloarthritis International Society criteria / ASAS 20 response;Timepoint(s) of evaluation of this end point: 16 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): 1- ASAS 40 response 2- Serum hsCRP 3- ASAS 5/6 response 4- Bath Ankylosing Spondylitis Disease Activity Index / BASDAI 5- Pre-filled syringe usability, possible hazard and patient satisfaction assessment 6- Overall safety and tolerability;Timepoint(s) of evaluation of this end point: 1 to 4: 16 weeks 5: Baseline to Week 16 6: 156 weeks	—

Countries

Belgium, Czech Republic, Germany, Greece, Mexico, Norway, Portugal, Russian Federation, Spain, United Kingdom, United States

Contacts

Public ContactMedizinischer Infoservice (MCC)

Novartis Pharma GmbH

infoservice.novartis@novartis.com+491802232300

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 8, 2026